MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON COMFORT FLO HUMIDIFICATION SYSTEM; RESPIRATORY GAS HUMIDIFIER

Catalog Number 2410

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The complaint was confirmed, via photo, however a root cause could not be identified.One picture of product p/n 2410 (comfort flo humidification system) was received for analysis.It was visually inspected, finding the kinked tube in circuit.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.The customer complaint was confirmed based on the visual inspection of the received picture.Although the complaint is confirmed based on the picture provided, there is no sufficient evidence to assure this issue was originated during the manufacturing process.The root cause for the condition reported could not be identified.(b)(4) facility will continue to track and trend this failure mode.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that the circuit is kinking during use.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The lot number was originally reported as 'unknown' by the customer; however, the returned sample was from lot number 74h1501753.A device history record (dhr) review was conducted on that lot number and there were no issues found that could relate to the reported complaint.The dhr shows that the product was assembled and inspected according to specifications.A visual exam was performed on the sample and it was observed that the heated limb was kinked at the proximal end to the column.The kink is indicative of a positioning issue.The tubing circuit material will not support angles of extension 45 degrees or greater.The tubing must either be routed higher than the column, or the column must be positioned lower than the distal end to ensure kinking does not occur.It should also be noted that this is not a corrugated tube which helps negate this issue, and this is a heated tube which softens it and causes the shape retention to relax, creating a kink.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed an issue with heated circuit positioning.The root cause for the failure has been assigned to the heated limb being over stressed during use.

Event Description

The customer alleges that the circuit is kinking during use.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).Method codes were accidentally omitted on follow-up #1.Follow-up #2 contains the method codes for the dhr review -(b)(4).

Event Description

The customer alleges that the circuit is kinking during use.No patient injury or harm reported.

• Brand Name: HUDSON COMFORT FLO HUMIDIFICATION SYSTEM
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5396772
• MDR Text Key: 37030083
• Report Number: 3004365956-2016-00088
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1